# K123464: Callisto Eye

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Mar 5, 2013 after 116 days
- Product code: NFJ (System, Image Management, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K896095 (1990). 16 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101861: Truevision 3D Visualization and Guidance System, Truevision Systems, Incorporated (2010) Summary page 3.

## Most influential descendants
- K141844: Rescan 700, Callisto Eye (2014), 5 descendants of its own
- K180858: CALLISTO eye (2018), 2 descendants of its own
- K231676: CALLISTO eye (2023), 1 descendant of its own
- K180229: RESCAN 700, CALLISTO eye (2019), 1 descendant of its own
- K233421: Rescan 700 (2024), 0 descendants of its own

## Indications for use
CALLISTO eye is an assistance system that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The system allows the remote control of the surgical microscope. The graphical guidance tools, as displayed on the CALLISTO eye Panel PC or microscope eye piece, aid the surgeon to insert, align, position, and register an artificial lens. These tools are intended for anterior segment ophthalmic surgical procedures, including positioning and angular alignment of toric intraocular lenses, limbal relaxing incisions, and capsulorhexis. The system utilizes surgeon information for positioning of graphical guidance tools.

Source page: https://510kreport.com/device/K123464
Methodology: https://510kreport.com/methodology